IntelliVue Patient Monitor MX750 (866471); IntelliVue Patient Monitor MX850 (866470)— 510(k) K221348
Substantially EquivalentPhilips Medizin Systeme Böblingen GmbH
FDA 510(k) clearance K221348 for IntelliVue Patient Monitor MX750 (866471); IntelliVue Patient Monitor MX850 (866470), Substantially Equivalent on 2023-02-03. Applicant: Philips Medizin Systeme Böblingen GmbH. Device class: 2.
Clearance details
- Device name as filed
- IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)
- Applicant
- Philips Medizin Systeme Böblingen GmbH
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boeblingen, DE
Recent devices under product code MHX
view allMore clearances from Philips Medizin Systeme Böblingen GmbH
view all- K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
- K253654 — IntelliVue Measurement Rack 6000 (867317)
- K251702 — IntelliVue Patient Monitor MX750 +2 more
- K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
- K242962 — Telemetry Monitor 5500 Release 4.0 (867232)
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.